Clin Data Assoc Ii

Thermo Fisher Scientific

1.6-3 years

Not Disclosed

India Remote

10 Dec. 31, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Associate II (CDA II)

Location: Remote, India
Job Type: Full-time
Category: Clinical Research / Clinical Data Management
Work Mode: Fully Remote
Job ID: R-01338260
Experience Required: 1.6–3 years

Company Overview

Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® clinical research portfolio, Thermo Fisher supports drug development programs across phases and therapeutic areas, partnering with leading pharmaceutical and biotechnology organizations worldwide.

With a strong footprint across 100+ countries and involvement in thousands of global clinical trials, Thermo Fisher Scientific delivers scientific excellence, operational rigor, and innovation at scale.

Role Overview

As a Clinical Data Associate II, you will play a critical role in ensuring data integrity, accuracy, and inspection readiness for global clinical trials. This position involves advanced data review, discrepancy management, reconciliation activities, and cross-functional collaboration to deliver high-quality, analysis-ready clinical datasets.

Working under GCP, global SOPs, and Work Practice Documents, you will contribute to complex studies and support regulatory-compliant clinical development programs.

Key Responsibilities

Clinical Data Management & Quality

Identify, analyze, and resolve data discrepancies and update clinical databases accordingly.
Generate, manage, and resolve data queries and clarifications in EDC systems.
Review data listings, validation checks, and data management reports for accuracy and consistency.
Perform Serious Adverse Event (SAE) and third-party vendor reconciliations.
Ensure compliance with study protocols, Data Validation Manuals, and regulatory requirements.

Study & Stakeholder Support

Prepare and deliver project-specific status reports for internal CDM leadership and external clients.
Collaborate with cross-functional teams including CRAs, medical monitors, biostatisticians, and vendors.
Contribute to CRF design implementation using designated graphical design tools, as applicable.

Education & Experience

Required Qualifications

Bachelor’s degree or equivalent in a relevant scientific or healthcare discipline.
1.6 to 3 years of experience in Clinical Data Management within CRO or sponsor environments.
Hands-on experience with RAVE / Veeva EDC platforms.

Knowledge, Skills & Competencies

Strong understanding of GCP, clinical trial processes, and regulatory guidelines.
Proficiency in managing clinical databases and interactive computer systems.
Excellent attention to detail with strong analytical and problem-solving skills.
Effective written and verbal communication with strong command of English.
Ability to interpret study protocols and clinical trial terminology.
Proven ability to work independently with moderate supervision and maintain data confidentiality.
Strong interpersonal skills with a customer-focused mindset and team-oriented approach.

Working Conditions

Remote office-based role with occasional interaction with clinical or operational teams.
Limited travel may be required depending on study or project needs.

Career Growth & Development

This role is part of Thermo Fisher’s Functional Service Provider (FSP) model, supporting a globally recognized biopharmaceutical sponsor known for innovation in specialty medicines and vaccines.

As an FSP professional, you will gain:

Exposure to high-visibility global studies and mature delivery models.
Opportunities for structured learning, mentorship, and career progression.
Potential advancement into roles such as Senior Clinical Data Manager, CDTL, CDM Project Manager, or transitions into Data Standards or Clinical Programming based on performance and business needs.

Why Join Thermo Fisher Scientific

Work on global, multi-phase clinical trials across diverse therapeutic areas.
Gain end-to-end exposure from study setup to database lock and close-out.
Build expertise in modern CDM technologies, including AI-enabled data workflows.
Collaborate with international teams, CRO partners, and sponsor organizations.
Contribute directly to bringing life-changing medicines to patients worldwide.

Equal Opportunity Statement

Thermo Fisher Scientific is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, gender, age, disability, veteran status, sexual orientation, or any other protected characteristic under applicable laws.

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Clin Data Assoc Ii

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